NEW HAVEN, Conn., Sept. 24, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ: IVVD) today announced the appointment of Paul B. Bolno, M.D., to its Board of Directors and as a member of the Compensation Committee. Dr. Bolno is the President and CEO of Wave Life Sciences, a clinical-stage biotechnology company, and has served in those roles since 2013. “We are happy to have Dr. Bolno join our Board at this critical moment while we transition toward a future focused on helping large populations avoid becoming il ...

Core Viewpoint - Invivyd, Inc. has successfully closed a public offering of 89,234,480 shares of common stock, raising approximately $57.5 million in gross proceeds before expenses [1][3]. Group 1: Offering Details - The offering included the full exercise of an underwriter's option to purchase an additional 14,423,076 shares at a public offering price of $0.52 per share [1]. - Pre-funded warrants to purchase 21,342,442 shares were also included, priced at $0.5199 each, which reflects the common stock price minus a nominal exercise price [1]. - Cantor Fitzgerald acted as the sole book-running manager for the offering, with RA Capital Management and Janus Henderson Investors leading the financing [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for trial protocol development and advancement of the VYD2311 clinical program [3]. - Funds will also support research and development for pipeline programs targeting respiratory syncytial virus (RSV) and measles, as well as efforts related to monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome [3]. - Additional uses include working capital and other general corporate purposes [3]. Group 3: Company Background - Invivyd, Inc. is a biopharmaceutical company focused on providing protection against serious viral infectious diseases, starting with SARS-CoV-2 [7]. - The company employs a proprietary integrated technology platform designed to develop and adapt high-quality antibodies [7]. - In March 2024, Invivyd received emergency use authorization from the U.S. FDA for a monoclonal antibody in its innovative pipeline [7].

Core Viewpoint - Invivyd, Inc. has submitted a Citizen Petition to the FDA advocating for a shift in the development approach for COVID-19 vaccines and monoclonal antibodies to restore public trust and enhance the effectiveness of preventive measures against COVID-19 and other viral diseases [1][6]. Group 1: Changes in Immunity and Virus Evolution - The immunological landscape in the U.S. has changed significantly since 2020, with most Americans now having some level of immunologic memory due to vaccinations or infections [2]. - The SARS-CoV-2 virus has evolved from the original Wuhan strain to more immune-evasive Omicron variants, leading to reduced vaccine efficacy against these newer strains [3]. Group 2: Vaccine Efficacy and Clinical Trials - There is a better understanding of the rapid waning of vaccine efficacy, necessitating long-term clinical evaluations rather than short-term studies [4]. - Invivyd's petition calls for new clinical trials to assess COVID-19 vaccines in a modern U.S. population, including seropositive individuals, and against contemporary Omicron variants, with efficacy measured over six months or longer [6]. Group 3: Monoclonal Antibodies and Regulatory Recommendations - Invivyd emphasizes the importance of developing non-vaccine solutions, such as monoclonal antibodies, to provide high-quality alternatives for the American population [6]. - The petition recommends that the FDA consider serum virus neutralizing antibody (sVNA) titers as a basis for Biologics License Application (BLA) approval, which would benefit patients and healthcare providers [7]. Group 4: Company Overview - Invivyd, Inc. is focused on delivering protection against serious viral infectious diseases, starting with SARS-CoV-2, and has received emergency use authorization for a monoclonal antibody from the FDA [8].

Core Viewpoint - Invivyd, Inc. will participate in the H.C. Wainwright 3rd Annual BioConnect Investor Conference, indicating active engagement with investors and stakeholders in the biopharmaceutical sector [1][2]. Company Overview - Invivyd, Inc. is a biopharmaceutical company focused on providing protection against serious viral infectious diseases, starting with SARS-CoV-2 [3]. - The company utilizes a proprietary integrated technology platform that is unique in the industry, aimed at assessing, monitoring, developing, and adapting to create best-in-class antibodies [3]. - In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody in its pipeline, highlighting its innovative approach and regulatory progress [3]. Investor Engagement - Management will host investor meetings at the conference, suggesting a proactive approach to investor relations and communication [2]. - A live webcast of the fireside chat will be available on the company's investor website, ensuring transparency and accessibility for investors [2].